Category Archives: Quality

In October, I had the privilege to visit Mumbai, India, to provide the keynote address at a series of Life-Science Executive Industry events on Quality and Manufacturing organized by Dassault Systèmes Biovia Corp.

This visit afforded me a great opportunity to meet with executives from many of India’s largest Life-Science companies, get a taste of Indian culture and share Axendia’s insights on trends impacting the global and externalized industry.

I also gained a new perspective on the Compliance vs Quality paradox.

During my keynote I emphasized the need for Life-Science Organizations to transition their focus from mere Compliance towards a culture driving Quality improvements across the organization.

Compliance is a Baseline, it is the cost of doing business in the Life-Sciences Industry. Collecting documented evidence of compliance with regulatory requirements is an overhead cost for Life-Science companies.

By contrast, Quality is an Investment. Improvements in quality drive enhanced and consistent product performance. In addition streamlined processes result in operational efficiencies and reduce waste. Investing in improving product quality lowers costs and improves outcomes

Axendia was recently briefed by ComplianceQuest’s executive team. The team, 80% of whom have deep experience in the Enterprise Quality Management Solutions (EQMS) market, has developed a cloud native EQMS built on the Salesforce platform.

ComplianceQuest was developed on the Salesforce cloud solution to provide a worry-free infrastructure platform that can be available anywhere, anytime. In addition, Salesforce provides a reliable, versatile infrastructure that can scale for all size companies. Another benefit of developing on the Salesforce platform is the ability to leverage advanced capabilities such as mobility, social media, artificial intelligence and machine learning and be ready for future technologies.

“ComplianceQuest provides a unique combination of niche experience, solutions and services across multiple industries with comprehensive capabilities in quality, safety and compliance throughout the supply chain,” said Nikki Willett, Chief Strategy Officer at ComplianceQuest. “Suitable for small companies and secure, scalable and flexible to meet the needs of medium and global enterprises, ComplianceQuest is easy to implement, validate and use,” she added.

In its Safety Communication, FDA confirmed that if exploited, these vulnerabilities could allow an unauthorized user with commercially available equipment to access a patient’s device and could be used to modify programming commands to the implanted pacemaker. This could result in patient harm from rapid battery depletion or administration of inappropriate pacing. At this point, there have been no known patient harm, however, the FDA has approved a firmware update that addresses these cybersecurity vulnerabilities and reduces the risk of exploitation and subsequent patient harm.

The FDA has been warning about cybersecurity on medical devices for over a decade. As Eric Luyer stated in his March 2017 article “the time to implement a proactive, comprehensive risk management program to eliminate cybersecurity threats is now”.

Cybersecurity of connected medical devices must be a key step in the design process. Medical Device manufacturers must be proactive instead of reactive to cybersecurity concerns when developing new products.

One of the basic tenets of investigative reporting is getting to the facts by asking ALL the relevant questions: Who, what, where, when and why? The issues, concerns and proposed solutions surrounding Data Integrity deserve no less a rigorous analysis.

While several articles have been published on data integrity addressing the: who, what, where and when, the most important question is left unanswered. WHY Is Data Integrity the Foundation of Good Science?

Answering who, what, where and when is a mechanical process.

Create a procedure requiring people to sign-wet or electronic: Who

Record the data element: What

Establish the source of the data element: Where

Record the time: When

The “Why” is the rationale for the procedure: “Data Integrity IS The Foundation of Good Science.”

Daniel Matlis, President of Axendia and Ashley Wentworth, Vaulty Quality Strategy at Veeva Systems presented thought leadership on this topic in an FDANews Webinar on March 22, 2017. Specifically, they discussed the importance of quality management across the global supply chain in FDA Regulated environments. Topics of discussion included:

Globalization and Outsourcing Trends in Life-Sciences

Regulatory Expectations for Outsourcing

Quality Metrics and Data Integrity

The Paradigm Shift in Quality Management

How to Source Quality Data and Benefits of a Cloud QMS

Modernizing Quality Management

Moving to Predictive Quality Organizations

Globalization and outsourcing has created unique opportunities and demanding challenges for the industry and regulators alike. Read More.

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